Table 3.
Study | Outcome measure | Baseline scores—population of interest (mean ±SD) | Follow up time point (months) | Follow up scores | Additional contextual findings |
---|---|---|---|---|---|
Vasovagal syncope | |||||
Baron-Esquivias et al. (26) | SF-36 (Spanish version) *data reported as median and interquartile range; means and SD estimated; physical and mental component summary scores calculated based on domain scores |
Physical functioning: 87 ± 22 Role physical: 56 ± 13 Bodily pain: 43 ± 12 General health: 61 ± 24 Vitality: 63 ± 34 Social functioning: 83 ± 28 Role emotional: 67 ± 75 Mental Health: 67 ± 27 Physical Component Summary: 50 ± 12 Mental Component Summary: 46 ± 18 |
6 | Physical functioning: 87 ± 22 Role physical: 85 ± 34 (p = 0.021) Bodily pain: 43 ± 12 General health: 67 ± 30 (p = 0.026) Vitality: 58 ± 26 Social functioning: 88 ± 28 (p = 0.03) Role emotional: 67 ± 75 Mental Health: 67 ± 27 Physical Component Summary: 51 ± 10 Mental Component Summary: 46 ± 18 |
At follow-up time point, patients who experienced syncope recurrence during the follow up period (n = 33; 38.3%) had significantly worse QoL in bodily pain, general health, vitality and role emotional domains than patients who did not have syncope recurrence. |
Van Dijk et al. (21) | SF-36 | Physical functioning: 68 ± 28 Role physical: 46 ± 45 Bodily pain: 64 ± 28 General health: 55 ± 23 Vitality: 50 ± 26 Social functioning: 68 ± 28 Role emotional: 65 ± 43 Mental health: 67 ± 22 Physical component summary: 44 ± 11 Mental component summary: 44 ± 13 |
12 | Physical functioning: 72 ± 29 (p
<
0.01) Role physical: 61 ± 43 (p < 0.01) Bodily pain: 71 ± 29) (p < 0.01) General health: 57 ± 25) (p = 0.08) Vitality: 57 ± 26 (p < 0.01) Social functioning: 76 ± 27 (p < 0.01) Role emotional: 71 ± 40 (p = 0.04) Mental health: 72 ± 20 (p < 0.01) Physical component summary: 46 ± 12 (p < 0.01) Mental component summary: 47 ± 11 (p < 0.01) |
All SF-36 scale scores improved at follow-up except general health. Effect sizes were small. Older age, higher level of comorbidity, having > 1 syncopal episode at presentation and syncope recurrence during follow up were associated with less improvement in physical component summary scores. Syncope recurrence during follow up and a neurologic or psychogenic syncope etiology were associated with less improvement in mental component summary scores. |
Sheldon et al. (31) Placebo arm (n = 98 BL; n = 59 completed study) |
SF-36 |
Physical Component Summary: 48 ± 10 Mental Component Summary: 46 ± 11 |
12 |
Physical Component Summary: 49 ± 10; NS Mental Component Summary: 48 ± 13; NS |
|
EQ-5D-3L | EQ-5D-3L index: 0.81 ± 0.22 EQ VAS: 74 ± 18 |
12 | EQ-5D-3L index: 0.86 ± 0.14 EQ VAS: 80 ± 14 |
||
Ng et al. (30) | SF-36 *physical and mental component summary scores calculated based on domain scores |
Physical functioning: 80 ± 24 Role physical: 65 ± 40 Bodily pain: 71 ± 24 General health: 66 ± 24 Vitality: 53 ± 23 Social functioning: 76 ± 25 Role emotional: 74 ± 38 Mental health: 70 ± 19 Physical Component Summary: 47 ± 11 Mental Component Summary: 47 ± 10 |
12 | Physical functioning: 84 ± 21 (p = 0.073) Role physical: 74 ± 38 (p = 0.066) Bodily pain: 74 ± 22 (p = 0.487) General health: 69 ± 21 (p = 0.056) Vitality: 60 ± 21 (p = 0.001) Social functioning: 83 ± 22 (p = 0.004) Role emotional: 83 ± 30 (p = 0.033) Mental health: 75 ± 16 (p < 0.001) Physical Component Summary: 48 ± 10 Mental Component Summary: 50 ± 9 |
Quality of life improved in patients with VVS after enrolling in a clinical trial, independent of randomization to drug or placebo and independent of syncope recurrence during follow up. Patients who experienced syncope recurrence during the follow up period tended to have lower quality of life scores at baseline (not significant) and had significantly worse quality of life scores in 5 SF-36 domains (social functioning, physical functioning, role physical, general health, bodily pain) at the 12-month follow-up time point. However, the overall improvement in quality of life from baseline to follow up was not affected by syncope recurrence during the follow up period. |
Lévesque et al. (39) | QLSI | Global QoL: 6.2 ± 5.32 Health: 7.9 Cognitive: 8.4 Social: 3.0 Marital relationships: 5.1 Leisure times: 6.1 Work: 5.2 Household chores: 5.5 Affectivity: 10.7 Spirituality: 0.7 |
2 | Global QoL: 4.0 ± 3.60 (p
<
0.0001) Health: 5.5 (p < 0.010) Cognitive: 5.3 (p < 0.010) Social: 2.6 Marital relationships: 3.0 Leisure times: 3.5 (p < 0.010) Work: 3.6 p < 0.010 Household chores: 3.0 (p < 0.010) Affectivity: 6.0 (p < 0.010) Spirituality: 1.4 (p < 0.0001) |
After controlling for lifetime syncope episodes, a significant improvement in global QoL and health, cognitive, leisure, work, household chores and affectivity QoL subscales was observed at 2- and 6-months following HUT (baseline). Spirituality subscale scores worsened at 2 months, then improved at 6 month follow up (compared to 2-month time point). QoL 2 months following HUT was worse in those who experienced a greater number of lifetime syncope episodes, those with little reduction in the syncope/presyncope frequency during follow up, those with anxiety/depressive disorders at baseline and a worse psychological profile at baseline. Younger age, reduced frequency of syncope/presyncope, a better baseline psychological profile at baseline (Psychiatric Symptom Index and Self-efficacy) and improvements in psychological profile during follow up were all associated with improvement in QoL during follow up. There was no effect of sex on quality of life improvement in the follow up period. There was a significant interaction between sex and syncope type; men with VVS (positive tilt test) exhibited better QoL compared to men with unexplained syncope (negative tilt test) (p < 0.017). All patients diagnosed with VVS reported receiving education and treatment for syncope, compared to only 53% of patients with unexplained syncope. Treatment and education for syncope were related to improvements in self-efficacy (p < 0.016), which was determined to be a significant predictor of improvements in quality of life (p = 0.002). |
6 | Global QoL: 3.7 ± 3.74 (p
<
0.0001) Health: 5.3 (p < 0.010) Cognitive: 4.9 (p < 0.010) Social: 2.4 Marital relationships: 4.2 Leisure times: 3.5 (p < 0.010) Work: 3.0 (p < 0.010) Household chores: 2.4 (p < 0.010) Affectivity: 5.7 (p < 0.010) Spirituality: 0.9 (p < 0.0001 vs. 2 month) |
||||
Gibbons et al. (48) POTS (control group n = 29) |
EQ-5D-3L | EQ VAS: 64 ± 9 | 6 | EQ VAS: 66 ± 8 (p = 0.52) | No significant difference in EQ VAS scores at 6-month follow-up in the control group. |
Bold text denotes statistical significance.